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FDA 510(k)

DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS

K-Number: K905829 · 1991-01-30

ApplicantKamiya Biomedical Co.
Decision Date1991-01-30
Product CodeCEL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Co.. It received FDA 510(k) clearance on 1991-01-30 under 510(k) number K905829. The device is classified under product code CEL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS?

DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS is a medical device that received FDA 510(k) clearance on 1991-01-30. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K905829.

When did DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS receive FDA 510(k) clearance?

DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS received FDA 510(k) clearance on 1991-01-30, under 510(k) number K905829.

Who is the listed applicant for DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS?

The FDA 510(k) record lists Kamiya Biomedical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS?

The FDA product code for DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS is CEL.

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Related Devices (Code: CEL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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